EU Quality Assurance Specialist & Auditor

About the job

Company Description Aurobindo Pharma (Malta) Limited is a fully owned subsidiary of Aurobindo Pharma Pvt Ltd, Asia’s largest generic pharmaceutical and API manufacturer. As a key part of a major vertically integrated pharmaceutical group, the Malta entity serves as the gateway for Aurobindo’s pharmaceutical products in Europe, supporting exports to over 125 countries. Established in 2008, the Malta operations provide analytical services, batch release, warehousing, and pan-European logistics. Team members collaborate with international colleagues and support high-quality, affordable medicines for markets across Europe and beyond.

About the Role

We are seeking an experienced Quality Assurance Specialist / Auditor to focus primarily on Quality Technical Agreements (QTAs) and GMP audits across suppliers, CMOs, and partners. The role will ensure agreements are maintained, audits are planned and followed up effectively, and key compliance risks are managed in line with EU GMP and internal quality requirements.

Key Responsibilities

• Quality Technical Agreements (QTA): Draft, review, negotiate, implement, and maintain QTAs with suppliers, CMOs, and partners, ensuring clear GMP responsibilities and compliance expectations.
• Audits: Plan, conduct, report, and follow up GMP audits of suppliers, CMOs, and service providers, including tracking observations through timely closure.
• Supplier/CMO oversight: Support supplier qualification, risk assessment, documentation review, and ongoing performance monitoring.
• QMS, documents, and EU guidance: Review and approve key quality documents, contribute to QMS activities as needed, and assess relevant EU GMP/EMA guideline updates for compliance impact.
• Cross-functional collaboration: Work with internal teams and affiliates to support quality and compliance objectives.

Qualifications

• Strong Quality Assurance and Quality Management skills, including experience implementing and maintaining pharmaceutical quality systems.
• In-depth understanding of Good Manufacturing Practice (GMP) and EU regulatory guidelines relevant to medicinal products.
• Experience in Quality Auditing, including participation in or execution of internal and external audits.
• Bachelor’s degree (or equivalent) in Pharmacy, Chemistry, Life Sciences, or a related discipline; advanced qualifications are an asset.
• At least 5 years of experience in a GMP-regulated pharmaceutical environment, ideally within EU regulation.
• Strong analytical, problem-solving, and documentation skills, with attention to detail and a structured approach to quality-related tasks.
• Effective communication, negotiation and teamwork abilities, with proficiency in English.